This is an open label, randomized, parallel group comparison of the immunogenicity safety of Wockhardt's human insulin and isophane insulin compared with the Novo Nordisk's yeast based human insulin products (marketed in USA) in type 1 diabetics.

There are two phases of the study, which are as follows:

Phase 1 is a comparative phase in which there will be 2 arms (which are described in the section below).

Phase 2 is a follow up phase only applicable to Wosulin Arm.

The study will last for 54 weeks for the patients enrolled in Wosulin arm and approximately 28 weeks for the patients enrolled in the comparator arm.

Two hundred and forty two patients will be enrolled considering an estimated dropout rate of 15% for a sample size of approximately 105 evaluable patients per arm. The total planned enrollment period for this study is approximately 3 months (90 days).

An Open Label,Randomized,Comparison of the Immunogenicity and Safety of Wockhardt's Human Insulin Basal Bolus Regimen With the Novo Nordisk's Yeast Based Human Insulin Basal Bolus Regimens, Marketed in United States, in Type 1 Diabetics.

Change in HbAlc from baseline to 6 months of treatment between Wosulin arm and Novolin arm(as surrogate indicator of change in insulin antibodies titers between the two treatment arms). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between change in HbA1c and change in anti insulin and insulin neutralizing antibodies. [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: No ]

Insulin dose will be used as a covariate

To compare the change from baseline in the level of serum anti insulin antibodies and insulin neutralizing antibodies between the two arms [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Compare the change in Insulin dose between the two arms [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Glycated hemoglobin levels and the number of hypoglycemic episodes will be the covariants for this analysis

Correlation of the immunogenicity with hypoglycemia, local allergic reactions and systemic allergic reactions will be evaluated. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]

Employee of Investigator or have direct involvement with trial or other trials under the direction of Investigator.

Those treated with other investigational agents or devices within previous 30 days, from screening, have planned use of an investigational drug or device, or have been previously randomized in this trial.

History or evidence of allergy to insulin preparations.

History or evidence of severe hypoglycemia (severe hypoglycemic episode defined as the subject required glucose, glucagon, orange juice etc administered by a second person)

Requirement for total daily dose of insulin is >1.4 units/kg

Who have received Wockhardt's (Wosulin) or Novo Nordisk's Insulin (Novolin® R, Novolin® N, Novolin® 70/30, in US and Actrapid® Insulatard®, and Mixtard® in India) during the previous one year.

Serum AIA level > 20 microU/ml.

Receipt of any insulin of an animal origin during the last 3 years.

Currently receiving or have received within the last year any immunomodulators medications, including corticosteroids that would possibly modify antibody generation either at the enrollment or during the course of the study. (Topical/ ophthalmic/intra-articular/nasal spray corticosteroids will be allowed).

Unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits.

History or evidence of active severe proliferative retinopathy, nephropathy and/or neuropathy significant cardiovascular disease, anemia or hemoglobinopathy, uncontrolled hypothyroidism or uncontrolled hyperthyroidism, alcohol or drug abuse or any other medical condition that in the opinion of Investigator can interfere with the study.

Judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01308437